allison mackinnon
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Proven IHN prevention Allison MacKinnon
Head Technical Services Aqua NA
Today’s Agenda
NAV Technology Video
Summary
2 Campbell River, British Columbia October 9, 2012
Innovation in Aqua
APEX-IHN® and Novartis
The Current Situation
2012 IHN Outbreaks
British Columbia
IHN confirmed on two farm sites in Tofino North and one farm in Sechelt
1.9 million fish eradicated at first affected farm in Tofino
Financial consequence
Lost revenue totaling millions
Eradication, disposal, and clean up costs
Disruption to future harvest plans
Industry consequences
Adds more fuel to environmental debate
Undermines confidence throughout the value chain
Campbell River, British Columbia October 9, 2012
Source: Canadian Food Inspection Agency
The Disease
Infectious hematopoietic necrosis (IHN)
Caused by a rhabdovirus that targets salmonids
Likely introduced to Atlantic salmon farms by returning Pacific salmon
IHN is endemic amongst more-resistant Pacific salmon
Highly infectious among farmed Atlantic salmon
Current outbreak shows it is very difficult to model and predict
Campbell River, British Columbia October 9, 2012
Source: World Organization for Animal Health. An OIE Collaborating Center, Iowa State University College of Veterinary Medicine.
The Disease
Campbell River, British Columbia October 9, 2012
Source: IHNV White Paper, 2003. Karreman and Stephen, eds.
TYPICAL MORTALITY CURVE for IHN in Atlantic salmon
The IHN virus spreads quickly –
and without warning
So what’s the best way to
control a lethal disease?
Campbell River, British Columbia October 9, 2012
Stop it before it starts.
Campbell River, British Columbia October 9, 2012
Innovation in Aqua
In 2001, Novartis began work on a technology
that would safely and effectively protect fish
against IHN.
The result was a new generation of vaccines
known as NAV vaccines or plasmid DNA vaccines.
Campbell River, British Columbia October 9, 2012
Innovation in Aqua
What is a NAV vaccine, exactly?
Rather than using whole viruses, Nucleic Acid
Vaccines are constructed using only the relevant
genetic components of the virus that trigger
antigen development.
These components are inserted into a circular
piece of nucleic acid called a plasmid.
Campbell River, British Columbia October 9, 2012
Innovation in Aqua
What is a NAV vaccine, exactly?
The plasmid can be injected directly into the muscle, without causing side effects,
and carries the information directly to cells around the injection point.
Campbell River, British Columbia October 9, 2012
Innovation in Aqua
What is a NAV vaccine, exactly?
The plasmid then instructs cells to produce antigens, which initiate an immune response
mimicking the natural infection of the virus.
The following video provides further explanation.
Campbell River, British Columbia October 9, 2012
NAV Video: Apex-IHN
Innovation in Aqua
Benefits of a NAV vaccine
A more powerful and targeted immune response without the need of an oil adjuvant
Reduced risk of side effects
No possibility of inducing the disease
Greater stability of the vaccine itself
Campbell River, British Columbia October 9, 2012
APEX-IHN® and Novartis
Why APEX-IHN® is the best way to
ensure your farm is protected against IHN.
Easy to administer
Safe for humans, the environment, and fish
Proven highly protective in salmon
Campbell River, British Columbia October 9, 2012
APEX-IHN® and Novartis
Ease of use: dosing and admin
Dose rate:
0.05 mL (50 microlitres) injection in the area
immediately anterior and lateral to the dorsal
fin in the epaxial muscle
Composition: Plasmid in saline solution
Adjuvant: None
Packaging: Ready-to-use flexible intravenous bag
Pack size: 250 mL (5000 doses)
Application:
Standard injection guns
0.5 mm X 3 mm stainless needles
Campbell River, British Columbia October 9, 2012
APEX-IHN® and Novartis
Safety assessment
Human safety
Self-injection by operator – no synthetic adjuvant hence very low risk
of inflammatory complications
Dosage – Fish vaccine dose relatively low (10 μg) as compared to the human
dose in clinical trials (100 – 300+ μg) where no adverse effects were reported
Declared safe for humans by Health Canada; poses no risk in food
Environmental safety
Plasmids are not organisms and are not self-replicating
Plasmids are non-infectious
Expression of the antigen already occurs in the natural environment
Vaccinated fish do not shed vaccine
Campbell River, British Columbia October 9, 2012
APEX-IHN® and Novartis
Safety assessment (cont)
Animal safety
Average mortality in Atlantic Salmon for three batches 1.5 % less than 6 %
as per requirements
No significant histopathological observations at the injection site (2x dose)
No lethargy, darkening, normal return to feed
Campbell River, British Columbia October 9, 2012
Source: IVVDC 2006, N.C. Simard. Data on file.
Proven efficacy
In an in-vivo vaccination challenge performed under controlled conditions, APEX-IHN®
proved to be well tolerated and highly effective at protecting Atlantic salmon against IHN.
APEX-IHN® and Novartis
Campbell River, British Columbia October 9, 2012
Challenge study –
4 months post – vaccination
Percentage mortality
of treatment groups
Field Performance
More than 60 million vaccinated since 2005
No reported adverse events of lack of efficacy claims since APEX-IHN® was licensed in 2005
No reported side effects or downgrades at harvest for the life of the product
No reported cases of IHN in vaccinated fish
Campbell River, British Columbia October 9, 2012
Summary
IHN virus continues to be a threat to the industry in BC
Increased surveillance of wild populations of Pacific salmon species
Better understanding of the risk factors associated with clinical disease
Increased research on the dynamics of shed / spread from wild populations
Proven Protection for plasmid DNA vaccine
No known treatment for IHN
Prevention needs to be part of Health Management Plan
Campbell River, British Columbia October 9, 2012
Thank you!
Campbell River, British Columbia October 9, 2012
NAAQ2012-001